Careers in Clinical Research Obstacles and Opportunities (1994) / Chapter Skim
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Executive Summary
Executive Summary
Pages 1-22
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This explosion of new information will introduce novel diagnostic and therapeutic modalities requiring highly skilled clinical investigators Mined to design and conduct human studies. For each new gene identified to be linked with a human disease, one has the potential to develop not only chemical approaches that use classical pharmacologic techniques but also new biological approaches that utilize the availability of appropriate biological products and, most recently, genetic 1
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Nevertheless, He explosion of the new knowledge in molecular biology, medicine, and health care, as well as in medical informatics will create the need for substantially more expertise—particularly for more fully trained physicians and other health professionals in academia, government service, and industry to transform these discoveries into cost-effective diagnoses and treahnents for human disease. Since most of these clinical investigators are trained in academia, it is important to recognize the crucial roles that academic health centers (AHCs)
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as a departure point, the special theme and focus of this study was patient-oriented clinical research, defined as that research which requires "handson" participation with a human subject. This subset of clinical research was defined as human research and was considered a subset of the entire spectrum of clinical research.
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A number of variables make the pursuit of clinical investigation relatively unattractive for medical students and students of the other health professions. These include the prolonged period of clinical training required of current medical graduates; the effect of He accumulated debt burden on career choice; the relative lack of role models and mentors; the perceived instability of research funding from NIH and other federal agencies; the real funding instability as it pertains to the individual investigator; the perceived lack of support for research, particularly as it relates to human research; the lack of emphasis on clinical research training in the curriculum; and the multiple demands upon the trainees not only during their period of training, but also as they begin their careers on the faculty, in industry, or in government service.
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The committee emphasizes that effective and strong leadership in academic health centers, in government, and in industry is a critical ingredient in the process for improving clinical research and developing rewarding clinical research career pathways. Whereas each individual recommendation is directed to a specific group or organization, collectively the recommendations represent a package of reforms needed for redefining careers in clinical investigation.
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From page 7... ...
NIH and over federal science agencies should prospectively collect data that document the extent to which patient-oriented clinical investigations are being supported and the success rates of such grant applications in the peer review process. At a minimum, this should include the collection of information and separate documentation as to the use of human materials, the study of human subjects, and the conduct of human epidemiology.
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Centers not only provide physical infrastructure but also serve as a locus of intellectual capital and collaboration necessary for conducting human research. The availability of small feasibility grants as part of larger center grants often stimulates investigators to extend their expertise to new areas beyond their current levels of interest.
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The perceived instability of federal funding for research, as well as the actual instability for the individual clinical investigator, appears to be an important obstruction in the choice of clinical research as a career for the young health professional. A multiyear commitment from the executive and legislative branches of the federal government for the support of NIH and other research agency appropriations would represent a major benefit to this perceived instability which often
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The committee believes, however, that there is a core of knowledge and skills common to clinical investigation that serves not only as the foundation for scientific discovery but also as the basis for clinical appraisal of evidence in decision making in health care for all health care professionals. Furthermore, if the problem with obtaining funding for human studies through peer review is the poor quality of grant proposals, action must be taken to improve the ability of newly independent investigators to draft sound proposals for clinical studies.
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degree appear to represent the most useful approaches to He production of highly qualified physician and dentist scientists and should be expanded The number of applications for these programs far exceeds the capacity; an expanded number of funded positions would be filled by highly qualified applicants seeking careers in clinical research. - Some of the positions should be designed to focus on Mining in human research.
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The committee believes that the pursuit of careers in clinical investigation may be seriously affected today by the prolonged period of training required, the instability of clinical research as a career option, and the modest levels of compensation that can be expected compared with those for other available career pathways for similarly [rained individuals. Existing programs that pay medical school tuition, such as the longstanding Medical Scientist Training (MSI)
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The committee urges the sponsors of clinical research and clinical research training to act independency to initiate programs of debt relief for these individuals. UNIVERSITIES AND ACADEMIC MEDICAL CENTERS The key to the success of individual clinical investigators is the university academic health center where most are likely to have acquired their research skills and where many conduct clinical investigation studies during a significant portion of their careers.
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Infrastructure The committee recommends that research institutions provide clinical investigators with the appropriate infrastructure in order to conduct high-quality clinical studies. In addition to well-trained and adequately funded patient-based clinical investigators, the successful execution of clinical and especially human research requires a suitable institutional infrastructure.
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Although this approach may not be possible in all settings, the committee recommends, as a minimum, a program that seeks out medical students and other health professionals with an ability and interest in research and that provides a concrete opportunity, it is hoped with funding, for a program of research training. The committee encourages over health professions to examine their training programs and curricula to ensure that Hey attract and support individuals capable of performing human research related to their professions.
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This includes the Liaison Committee for Medical Education, the Accreditation Committee for Graduate Medical Education, the Accreditation Committee for Continuing Medical Education, the Joint Commission for Accreditation of Health Care Organizations, and the accreditation bodies for other health professions. In addition, Here is a voluntary certification process to recognize individual qualifications in pursuit of specialty careers in organized medicine and dentistry.
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The committee believes that LCME must play a key role in effecting changes in medical school curricula that will encourage lifelong learning and intellectual curiosity. Such curriculum changes in medical schools, as well as changes in other health professional schools, must recognize the crucial role of scientific inquiry and incorporate necessary changes that are supportive of individuals pursuing research career pathways, particularly clinical research pathways.
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The certifying boards of ABMS, which establish the basic requirements for individuals to receive certification in specialty disciplines, should be strongly encouraged to develop specific clinical investigator pathways to allow individuals who pursue their disciplines to substitute experience and training in clinical investigation for other requirements. Familiarity with clinical research methodologies and interpretation should be tested dming the cer~cation process.
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or public-sector organization with combined funding from the federal government and the private sector. For clinical research, which the committee views as critical to national security and economic competitiveness, such an organization could include funding and representation from the federal science agencies, the pharmaceutical and biotechnology industry, third-party payers, the health and life insurance industries, and other interested groups.
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Healthy relationships that encourage full cooperation can build on this interdependence and can be synergistic. Preserving Academic Health Centers The committee emphasizes that the federal government and third-party payers recognize the vital contributions that academic health centers (AHCs)
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Graduate medical education is not the only factor that accounts for the higher costs at AHCs. Health care professionals at AHCs often treat patients who are more seriously ill, provide infrastructure for biomedical and health services research, and offer clinical training experiences for undergraduate medical and other health professional students—costs that add to an institution's cost base.
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Graduate medical education is not the only factor that accounts for the higher costs at AHCs. Health care professionals at AHCs often treat patients who are more seriously ill, provide infrastructure for biomedical and health services research, and offer clinical training experiences for undergraduate medical and other health professional students-costs that add to an institution's cost base.
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